In the Philippines, oversight of medical device registration falls under the jurisdiction of the Center for Device Regulation, Radiation Health, and Research (CDRRHR) within the Department of Health. (AMDD) ASEAN Medical Device Directive provided the list of documents needed for the registration of Medical Devices as per the Classification.
Time frame to obtain the LTO is between 1 – 3 months.
| Classification Type | Risk Level | Review Time | Application Fee |
|---|---|---|---|
| Class A Notification (CMDN) | Low | 4 to 12 weeks for authentication | PhP 7,500 |
| Class B Registration (CMDR) | Low-moderate | Within 6-9 months | PhP 7,500 |
| Class C Registration (CMDR) | Moderate-high | Within 6-9 months | PhP 7,500 |
| Class D Registration (CMDR) | High | Within 6-9 months | PhP 7,500 |
The current product classifications in the Philippines adhere to the ASEAN Medical Devices Directive, with categorizations ranging from low to high risk (Classes A, B, C, and D). The review time and registration fees vary according to the risk level. It’s important to note that In Vitro Diagnostic (IVD) devices have separate regulatory requirements under an upcoming Administrative Order.
| Aspect | Details |
|---|---|
| Validity Period | CMDNs and CMDRs are valid for 5 years. |
| Renewal | Renewal must be done every five years after the initial approval. |
| Renewal Filing Period | Renewals can be filed 90 days before the expiry of the CMDR or CMDN. |
| Renewal Fee | A fee of PhP 5,150 (US $110) is applicable for renewal, which generates a fresh CMDN valid for 5 years. |
| Registration Timeline | 6 – 9 Months |
